What is the Company's Core Safety Information (CSI)?
Lilly maintains a Core Safety Information (CSI) document for each marketed drug, which contains all relevant safety information that Lilly requires to be listed in all countries where the drug is marketed.
Both identified risks and potential risks that may have prescribing implications, (impacting physicians' decisions about treatment or clinical management of a patient) are included in the CSI.
What is the link between the company CSI and the local label/prescribing information?
When new safety information is included in the CSI, Lilly communicates these changes to regulatory authorities in all the countries where a product is marketed and requests that the local label be updated to reflect the information.
Ultimately, the content of a local label is contingent upon approval by the local regulatory authority and subject to local laws and regulations. As such, additional information of national or local interest or need may be required beyond the CSI. There may be instances when a regulatory authority may request substantial changes to (or even removal of) information to be included in the CSI and submitted for approval by Lilly.
In the U.S., pharmaceutical companies are expected to include important new safety information in the Prescribing Information without prior approval by the FDA (through a process called a "Changes Being Effected"), as a means to rapidly disseminate the information to prescribers and patients, while the FDA's review is underway.
Changes to the local label may also entail changes to the risk management plan, including risk minimization elements.